Medical Laboratory Technologist/Sr Medical Laboratory Scientist (QC), NCIS(8282) - Geylang

Overview*

NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of expansion of its Specialized Programmes and to become a Reference Centre of Excellence. We are looking for a Quality Control (QC) Specialist for the QC department in the organization.

The candidate will execute the assigned Quality Control Testing (e.g. Raw Material Testing, In-process testing, Final Product Testing, Analytical Science and Technology, Environmental and QC Systems, for NCIS Specialized Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and other provided services.

• Responsible for routine testing which includes analytical, bioanalytical, microbiological and/or environmental samples testing, depending on the technical role assigned.
• Coordinating and scheduling of testing activities.
• Ensure all critical materials, reagents and consumables required for testing are available.
• Coordinate procurement and provide URS of materials for QC usage which includes consumables, reagents, test media, test cultures, small equipment, glassware, plasticware etc.
• Coordinate shipment of samples and QC materials.
• Ensure all laboratory operations including test execution, review and data documentation are performed according to cGMP procedures.
• Participate in creating SOP, reviewing SOP, equipment qualification and method verification/validation activities.
• Coordinate/Perform calibration and preventive maintenance of laboratory equipment
• Initiate quality document such as out of specification investigation, deviation record, change control etc if necessary.
• Support in the timely resolution of issues, including discrepancies, investigations and implementation of CAPAs.
• To support supervisor/manager in reviewing protocols/reports/SOPs and other documents assigned by the supervisor/manager.
• Participate in method validation/method verification activities which include protocols preparation and review.
• Perform trend analysis of test data that are essential for monitoring purpose.
• To conduct training as subject matter expert in the test methods, systems and equipment assigned.
• Supports improvement initiatives, programs and projects driven from the Quality Management System
• Support as subject matter expert during internal and external audits/inspections.
• Escalates quality and compliance risks to QC Management and QA.
• Any other responsibilities assigned by the QC Management
• Note: Other responsibilities may be assigned.

• Bachelor or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference of more than 2-4 years of relevant work experience in Quality Control role in the pharmaceutical/biotechnology/medical device/healthcare industry.
• Good knowledge of quality control, quality management system and validations requirement, preferably with third party customer/supplier or vendor management experience.
• Good knowledge in regulations and industrial guidance especially for stem cell / cell and gene therapy
• Good communication and able to engage stakeholders effectively from different functional units
• Critical thinking and problem-solving skill are of advantage.